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Studying Urine and Blood Samples in Women With Newly Diagnosed Breast Cancer

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Completed

Conditions

Breast Cancer

Treatments

Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: medical chart review
Genetic: mutation analysis
Genetic: DNA analysis
Procedure: evaluation of cancer risk factors
Other: questionnaire administration

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00766454
CCCWFU-98298
P30CA012197 (U.S. NIH Grant/Contract)
CCCWFU-BG98-278
CDR0000573065

Details and patient eligibility

About

RATIONALE: Studying samples of urine and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This study is looking at urine and blood samples in women with newly diagnosed breast cancer.

Full description

OBJECTIVES:

  • To determine the association between the genotype for 4 metabolic enzymes (e.g., CYP1A1, GSTM, GSTT, and GSTP) in women with newly diagnosed breast cancer that play key roles in the metabolism of environmental human carcinogens and the risk of breast cancer development.

OUTLINE: Urine and blood samples are collected for DNA, mutation, and polymorphism analysis. The biological samples may be stored and used for future research.

Patients complete a Baseline Questionnaire to collect basic risk/exposure information, including demographic factors (e.g., age, weight, height, and body mass index), menstrual/reproductive history, medical history, medication use, smoking history, alcohol consumption, exposure to chest x-ray, and family history of breast cancer in first-degree relatives. Patients also complete a Second Hand Smoke Questionnaire to collect information on cigarette smoking history and second hand smoke exposure and a Food Frequency Questionnaire to collect information on the frequency of use of specific fruits and vegetables (e.g., cruciferous vegetables) and to estimate usual dietary intake of 33 nutrients during the past year (e.g., total fat, saturated fat, oleic fat, linoleic fat, carbohydrates, protein, vitamins [e.g., A, B1, B2, niacin, B6, folate, C, and E], minerals [e.g., calcium, magnesium, iron, and zinc], electrolytes [e.g., sodium and potassium], and dietary fiber). Patients' medical charts are also reviewed to collect information on age, gender, ethnic background, medical history, and medical care.

Enrollment

1,104 patients

Sex

Female

Ages

Under 120 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Newly diagnosed breast cancer
  • Planning to undergo a diagnostic biopsy or surgery
  • Must have tumor tissue available
  • Hormone receptor status not specified
  • More than 6 months since prior chemotherapy or radiotherapy
  • Pre- or post-menopausal

Exclusion criteria

-Psychiatric history that would preclude giving informed consent

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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